Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.

This study compared the effects of mechanical and manual traction on pain, disability and lumbar spinal curvature in patients with discogenic low back pain

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Low Back Pain, Mechanical; Disc Degeneration; Lumbar Radiculopathy; Disc Prolapse; Disc Prolapse With Radiculopathy
• Intervention / Treatment: Procedure: Hot Pack; Procedure: Manual Traction; Procedure: Joint Mobilization; Procedure: TENS; Procedure: Mechanical Traction

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Foundation University Institute of Rehabilitation Sciences.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with discogenic low back pain,
• Patients of both genders
• Age ranges from 20 to 60 years
• NPRS > 5

Exclusion Criteria:

• Patients with non-mechanical back pain
• Patients with known metabolic diseases,
• Osteoporotic patients,
• Recent history of spinal trauma or surgery,
• Lumbar myelopathy,
• Cauda equine syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Traction; Moist heat packs & TENS for ten minutes followed by Manual Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient.	Procedure: Hot Pack; Superficial Heating; Procedure: Manual Traction; Manual Traction for 10 minutes; Procedure: Joint Mobilization; 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions; Procedure: TENS; TENS for 10 minutes with hot pack
Experimental: Mechanical traction; Moist heat packs & TENS for ten minutes followed by Mechanical Traction and 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions firstly but modified as per the response of the patient	Procedure: Hot Pack; Superficial Heating; Procedure: Joint Mobilization; 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions; Procedure: TENS; TENS for 10 minutes with hot pack; Procedure: Mechanical Traction; Mechanical Traction for 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.	6 weeks
Oswestry disability index	Changes from base line The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.	6 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad
• Investigators: Principal Investigator: Furqan Yaqoob, PhD*, Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Prolapse; Intervertebral Disc Degeneration; Radiculopathy
• Other Study ID Numbers: FUI/CTR/2021/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No